The Protocol Review and Monitoring System (PRMS) ofthe Duke Comprehensive Cancer Institute (DCCI) consist ofthe Cancer Protocol Committee (CPC), into which the Cancer Sciences Subcommittee (CSS) is Incorporated, and the Scientific Monitoring Subcommittee (SMS). The mandate of the CPC is the scientific review of new cancer-related protocol applications. The CPC reviews new therapeutic protocols (agent or device) and non-agent or device interventions and non-interventional research (correlative sciences, cancer prevention and control, diagnostic and psychosocial research). The charge of the CPC is to assess a study's access to cancer patients based on a protocol's scientific merit, the Center's priorities, and the feasibility for completing the study in a relevant period of fime. The SMS is charged with the scientific monitoring of institutional protocols, encompassing reviews for scientific process and reports of on-site audits of institufional protocols. The SOP 19-1 covers the PRMS. The PRMS is supported administratively by the Clinical Trials Shared Resource.